The application area for the I-SMART project is the in vitro diagnostics sector. The purpose of the I-SMART project is to develop an innovative kit for a simple, rapid and minimally-invasive molecular diagnostic test for personalized oncology diagnosis.

In the treatment of cancer diseases the personalized medicine is assuming an important role, the use of aimee therapies and “smart drugs“ will ensure a more effective opposition to the illness.

In this context, combination between: typing, identification of the individual's genetic characteristics and scientific discoveries related to molecular mechanisms that underlie the onset and possibly the progression of tumors, have assumed a significant role in drug development.

In some circumstances, a particular therapy is not suitable for certain patients, who respond in an unexpected way due to their own mutational fingerprint or to the expression of a few key genes. Today, is possible to identify in advance whether a particular patient will benefit from a particular therapy, so as to ensure the best therapy is made quickly available.

Breast cancer is the neoplastic disease most common in the female population, affecting one out of every nine women at some point in her life. In cases of breast cancer, the ability to diagnose the cancer in relation to its receptor and mutational structure is crucial for neo-adjuvant or preoperative therapy.

The I-SMART project aims to develop a relatively non-invasive molecular diagnostic kit, based on Real-Time PCR technology, that is capable of performing a rapid, simple, cost-effective mutational and transcriptional analysis of responsive predictive genes from tumor samples.

Furthermore, ones of the aims of the I-SMART project is to set up the assay for use with specimens taken with fine-needle aspiration, currently used only for the preliminary cytological analysis. This procedure will allow the molecular analysis to be performed on relatively non-invasive samples (from fine-needle aspiration), this will avoid the discomfort of other far more invasive methodology and ensure drastic reductions in both time and costs for the diagnosis.

Starting date: 04/18/2017

End date: 06/30/2018

Total project: € 474.121,50

Total grant: € 340.002,39



Alphagenics Biotech S.r.l.

Alphagenics is one of the most qualified national companies in the use of innovative molecular biology techniques, suitable both for clinical use and research in the medical and environmental fields, for the in-depth analysis of prognostic/diagnostic issues.

Aphagenics focuses on the research, development and production of testing kits. The company provides consulting services for the technology transfer of new projects, and its R&D department is engaged in the development of new technologies and the design of custom solutions to fully meet the market’s needs. The company has developed different systems for the molecular typing and quantification of viral genomes (HPV/HCV) using reverse dot/blot, real-time PCR and ELISA methodologies. The company also offers a full panel of prognostic kits, based mainly on real-time PCR technology, for some of the most important cancers, such as kits for colon and gastric carcinoma (ARKRAS e ACMSi), thyroid, colon and melanoma cancer (ARBRAF), glioblastoma (ARMGMt), lung cancer (A lEGFR) and an innovative prognostic kit that provides the probability of breast cancer recurrence (ARBREASt). Tests are highly reproducible, sensitive and rapid.

Dotcom S.r.l.

Dotcom was founded in April 2004 by a group of young professionals who have been working in Information Technology for years. The expertise and services offered by the company include document management solutions, medical software development, applications for enterprise automation processes, product development based on the OpenSource platform and dissemination of OpenSource products and technologies.


Dotcom collaborates with large companies and public administrations in Italy and abroad. Research, development and innovation are elements that characterise the Dotcom corporate identity and are key factors for enhancing its competitiveness on the market.

Laboratorio Nazionale del Consorzio Interuniversitario per le Biotecnologie (LNCIB) – P Partner

LNCIB was founded in 1987 as a consortium of 25 Italian universities that aim to promote and coordinate the scientific research and the technology transfer in the fields of biotechnology, agro-food, industrial, pharmaceutical, zootechnical, veterinary and environmental sectors, by the involving the research units of the associated universities.


Since its inception, the consortium has been dealing with the:

  • development of procedures for the processing and molecular analysis of oncology and infectious diseases of clinical samples using lab-on-a-chip technology;
  • development and optimisation of bioinformatic procedures for analysis of public or experimentally generated data; and
  •  study and characterisation of key molecular bases in tumour etiopathogenesis.


Specific competences include:

  •  Optimisation of nucleic acid extraction procedures from biological samples and molecular analysis in multiplex (microarray or real-time PCR miniaturised systems) integrated into Point-Of-Care (POC) microfluidic systems.
  • Functional characterisation of onco-suppressors
  • Investigation of genomic instability, metabolism and cell transformation
  • Epigenetics in tumour stem cells
  • Functional genomic studies (ChIP-Seq, RNA-Seq, etc.)
  • Non-coding microRNA and RNA studies
  • Drug discovery and functional screening